Director, Pharmacovigilance

Overview

In this role you will lead global pharmacovigilance for Orchard’s gene therapy programs, ensuring safety and benefit-risk integrity across investigational and marketed products. You will collaborate with cross-functional teams to develop and implement product-specific safety strategies and engage with Health Authorities on safety matters. As the medical monitor, you provide clinical oversight to safeguard participants and data quality while upholding regulatory standards. This position offers a chance to shape safety governance in a cutting-edge therapy portfolio and to drive proactive risk management.

Responsibilities

• Lead strategy, review, and finalization of aggregate safety reports (PSURs, DSURs) for assigned products
• Oversee core risk management strategy, risk assessment, and risk minimisation; manage risk management plans and PV plans
• Direct signal management processes and chair safety management meetings; produce signal evaluation reports
• Provide medical input on safety questions from regulators and internal stakeholders; train teams on signal management when needed
• Review and analyze safety data from post-marketing and clinical studies; contribute to literature monitoring as needed
• Collaborate with cross-functional teams on protocol reviews, data analysis, and safety activities for investigational programs
• Provide ongoing medical data review and interpretation; oversee SAE reviews and sponsor oversight
• Communicate safety issues to senior management and support clinical development teams as pharmacovigilance advisor
• Engage with regulatory authorities and respond to safety questions with input from PV scientists
• Lead and collaborate on safety-related investigations and data clarifications in real time
• Manage PV systems oversight (e.g., Veeva safety database) to meet global regulatory requirements
• Develop and deliver internal training on PV processes and governance

Key requirements

• Minimum 7 years in pharmaceutical industry or clinical care setting
• Director level with MBBS or equivalent (physician by training)
• Demonstrated 3–5 years in drug safety with direct EU and ROW regulatory interactions
• Strong understanding of GCP, ICH guidelines and pharmacovigilance practices
• Experience as medical monitor in clinical trials (Phase I/II and/or gene therapy)
• Familiarity with neurometabolic diseases
• Ability to work independently and manage deliverables in a dynamic environment

• leadership
• strong communication and editorial skills
• cross-functional collaboration
• Veeva Safety database and PV systems
• signal detection and management
• PSUR/DSUR development and pharmacovigilance planning

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